Renal denervation is a minimal invasive procedure used for the treatment of drug resistant or treatment resistant hypertension. This procedure reduces blood pressure by ablation of renal nerves. With rising incidences of uncontrolled and treatment resistant hypertension, demand for RDN devices is expected to grow in future. Benefits of the RDN procedure such as shorter treatment time and permanent effects over drug treatment, which indirectly reduces the cost of treatment, will also accelerate the market growth. Furthermore, increasing awareness of the RDN process and expected approvals from regulatory bodies such as FDA will boost the demand for RDN devices globally.
WHO estimates indicate that in 2012 more than 1.2 billion people were suffering from hypertension. Clinical data collected from various regions shows the global prevalence of hypertension to be about 38% to 45%. Moreover, new data released by National Health and Nutrition Examination Survey (NHANES) indicates the occurrence of hypertension in the US to be around 30%. After studying data from various clinical studies it is observed that more than 25% to 45% of hypertensive people suffer from uncontrolled hypertension and 15% of these people are observed to have treatment resistant hypertension. This represents a positive outlook for RDN procedure as it considerably reduces the blood pressure in patients with treatment resistant hypertension, thus providing a huge basis for growth of the market.
Europe is the largest as well as fastest growing regional market for RDN devices followed by Asia-Pacific. Europe is expected to maintain its dominating position with a strong double digit growth through 2021. The RDN devices market in North America is expected to accelerate due to FDA approvals in the next 4-5 years coupled with the high incidence of lifestyle-related cardiovascular diseases in the region. Aging population along with a high incidence of diabetes will boost the demand for RDN devices in Asia-Pacific, which is estimated to have a large percentage of population that has not even been diagnosed. Large numbers of hypertensive people have not yet been diagnosed with uncontrolled hypertension globally and are still trying many alternate therapies and medications and struggling to control hypertension.
Due to insufficient clinical data, market players are currently struggling to get approvals from regulatory bodies. However, some leading players have received certification by adding innovation to their products coupled with strong research and development activities. Currently, only five devices have received approval for CE mark certification which includes Medtronic’s Symplicity, Boston Scientific’s (Vessix Vascular) V2, St. Jude’s EnligHTN, Covidien’s OneShot and ReCor Medical’s Paradise with not a single RDN therapy receiving approval from the US FDA. Medtronic is the leading player in the RDN devices market and contributes for more than 85% of the global market share. ReCor Medical Paradise is the only ultrasound denervation system that has CE certification. However, in the coming years, a high threat of new entrants is expected with innovative technologies which will reduce procedure time and have greater efficacy. Yet with all the challenges, the renal denervation procedure is considered a boon to treatment of uncontrolled hypertension and thus, the market growth in coming years is expected to be very strong.
Global Renal Denervation Devices Market: Snapshot
Renal denervation involves a minimally invasive procedure for the treatment of hypertension that is resistant to drugs or other medical treatment. As per a study published by the National Health and Nutrition Examination Survey, the prevalence of hypertension in the U.S. is approximately 30%. Clinical studies further reveal that 15% of hypertensive people have treatment resistant hypertension. This exhibits a positive outlook for renal denervation (RDN) procedures as it helps to normalize the blood pressure among patients with treatment resistant hypertension.
The report on the renal denervation devices market is segmented on the basis of technology, product, and region. Radiofrequency-based RDN devices display substantial demand due to benefits of efficiency and safety.
The report presents a quantitative and qualitative critical analysis of the global renal denervation devices market based on vital market indicators such as demand drivers, restraints, and growth opportunities. Each and every segment is carefully analyzed employing standard analytical tools to present its growth trajectory and market share projections.
Global Renal Denervation Devices Market: Trends and Opportunities
Rising incidence of hypertension among the urban population has been a significant growth driver for the global renal denervation devices market. RDN procedure offer benefits such as shorter treatment time and permanent cure over drug treatment, which reduces the overall cost of treatment in the long run. Thereby accelerating the market’s growth. Furthermore, awareness of RDN procedure and product approvals from FDA is likely to favor the RDN devices market.
Hypertension involves directly impacting the renal sympathetic nerves. The increasing prevalence of uncontrolled hypertension and treatment resistant hypertension are some other key factors contributing to the market’s growth. Long lasting effect and shorter treatment duration of renal denervation procedure are likely to positively reflect on the RDN devices market. Further, rapid upgrade of RDN devices and a rising geriatric population globally are likely to bode well for the global renal denervation devices market.
However, inadequate data pertaining to the efficacy of RDN procedure is challenging the market’s growth. Lower awareness of RDN procedure over drug based therapy along with lack of favorable reimbursement policies for RDN procedure accounts for slow uptake.
Global Renal Denervation Devices Market: Geographical Analysis
Currently, Europe holds the top rank among other key markets for renal denervation devices market. Expanding at a double-digit growth rate, the region is anticipated to hold on to its dominant position through the forecast period.
North America RDN devices market could accelerate on the back of product approvals from FDA in the next 4-5 years along with an increasing incidence of cardiovascular diseases.
Nonetheless, Asia Pacific could emerge as a lucrative market for RDN devices market due to a growing aging population with high incidence of diabetes, of which a large percentage of the population that has not even received a diagnosis. Further, a large population of hypertensive patients in the region that have not been diagnosed with drug or treatment resistant hypertension, and are trying several alternate therapies and medications for a remedy for the condition.
Global Renal Denervation Devices Market: Competitive Analysis
The renal denervation devices market is oligopolistic in nature with more than 85% market share held by Medtronic. Stringent regulations and long hauls for product approvals limit the number of vendors in this market. Currently, only five devices have received CE mark certification, which includes Boston Scientific’s V2, Covidien’s OneShot, St. Jude’s EnligHTN, and Recor Medical’s Paradise with none of the devices obtaining US FDA approval.
However, the market is anticipated to witness the entry of new players to offer innovative products with reduced procedure time and greater efficacy.
The global renal denervation devices market is segmented as follows:
Global Renal Denervation Devices Market, by technology
- Ultra-sound based renal denervation systems
- Renal Sympathetic Denervation Procedure
- Micro-infusion catheter-based renal denervation systems
- Radiofrequency-based renal denervation systems
Global Renal Denervation Devices Market, by product
- Medtronic- Symplicity Renal Deneravtion System
- St Jude Medical – EnligHTN Multi-Electrode Renal Deneravtion System
- Covidien- OneShot
- Boston Scientific – V2 Renal Denervation System
- ReCor Medical – PARADISE Technology
- Other Emerging Technologies
Global Renal Denervation Devices Market, by geography
- North America
- Asia Pacific
- Rest of the World
The global renal denervation devices market is expected to grow at the compounded annual growth rate of 139.7% by the year 2015 owing to increasing number of population suffering from hypertension. This market is also witnessing the trend of increasing usage of minimally invasive procedures; however, preference for drug based therapy from patients may pose a serious challenge to the growth of this industry. Renal artery denervation is a new device based therapeutic model designed for treatment of hypertension and is gaining popularity among medical device entrepreneurs. Although renal denervation devices industry is in its developing phase, it has attracted most large players for investing in this industry due to the tremendous growth potential of this market.
Renal denervation is a catheter based therapy that makes use of radiofrequency or ultrasound energy for disrupting the renal arteries nerves whose hyperactivity may lead to treatment resistant hypertension. Real denervation devices offer complementary approach to the management of resistant hypertension. Aging population and increasing health issues due to hypertension is giving rise to the use of renal denervation devices. Advancements in technology and emergence of new market players are also boosting the growth of this industry.
- Based on Technology
- Renal Artery Denervation Procedure
- Radio Frequency Renal Artery Denervation Systems
- Ultrasound Renal Artery Denervation Systems
- Microinfusion Renal Denervation Systems
This research report analyzes this industry based on its market segments and major geographies. Geographies analyzed under this report are North America, Europe, Asia Pacific and Rest of the World.
This research report also includes complete analysis of
- Current market trends
- Industry drivers
- Factors limiting market growth
- Industry structure
- Market projections for upcoming years
Report also provides analysis of recent technological developments in this industry, Porter’s five force model analysis, and complete company profiles of top industry players. This report includes review of micro and macro factors significant for existing market players and new entrants along with detailed value chain analysis.
Some of the major players dominating this industry are Boston Scientific Corp., Medtronic Inc., ReCor Medical Technology, St. Jude Medical Inc, Ardian, CardioSonic, Covidien, Kona Medical, Maya Medical, Mercator MedSystems, Vessix Vascular and others.